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STM-416 for Bladder Cancer

Phase 1 & 2

Recruiting

Led By Boris Gershman, MD

Research Sponsored by SURGE Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have adequate organ and marrow function as defined below: Hemoglobin 9.0 g/dL, Absolute neutrophil count 1.5 × 109/L (1500 per mm3), Platelet count 75 × 109/L (75,000 per mm3), Serum bilirubin 1.5 × institutional upper limit of normal (ULN), AST/ALT 2.5 × institutional ULN, Creatinine CL 60 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine CL

Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion up to 24 months

Awards & highlights

Study Summary

This trial tests a new drug in people with bladder cancer to see if it's safe & tolerable.

Who is the study for?

This trial is for adults over 18 with high-risk recurrent bladder cancer who are undergoing TURBT. They must have a certain level of physical fitness (ECOG 0-2) and adequate organ/marrow function. Excluded are those with invasive or carcinoma in situ bladder cancers, on other trials, allergic to similar drugs as STM-416, women who can become pregnant (only in early phases), and anyone with serious infections or unstable health conditions.Check my eligibility

What is being tested?

The study tests STM-416's safety and tolerability in patients with bladder cancer. It's the first time this drug is being tried on humans (Phase 1/2a). The trial involves increasing doses to find out what amount is safe and how well it works when given during TURBT surgery for recurring non-muscle-invasive bladder cancer.See study design

What are the potential side effects?

Since this is a first-in-human study of STM-416, specific side effects aren't yet known but may include typical reactions related to immune system activation such as fever, fatigue, skin reactions at the injection site, flu-like symptoms, and potential impacts on blood counts or liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood counts and liver/kidney functions are within safe ranges.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Phase 1

Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 1

Recurrence free survival time (Phase 2a)

Secondary outcome measures

Pharmacodynamics of STM-416

Pharmacokinetics of STM-416 (Phase 1)

Trial Design

1Treatment groups

Experimental Treatment

Group I: STM-416Experimental Treatment1 Intervention

STM-416

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

SURGE TherapeuticsLead Sponsor

1 Previous Clinical Trials

18 Total Patients Enrolled

Boris Gershman, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center

Seth Lerner, MDPrincipal InvestigatorBaylor College of Medicine

Media Library

STM-416 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05710848 — Phase 1 & 2

Bladder Cancer Research Study Groups: STM-416

Bladder Cancer Clinical Trial 2023: STM-416 Highlights & Side Effects. Trial Name: NCT05710848 — Phase 1 & 2

STM-416 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05710848 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new enrollees being accepted into this investigation?

"According to the information on clinicaltrials.gov, this specific trial is not accepting patient enrolment at present; it was first listed in March 1st of 2023 and last edited on March 21st of the same year. Although no longer enrolling patients for this particular study, 318 other trials are actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer

2023. "A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05710848.